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Clinical Trials in Germany / NCT07211958
Recruiting Phase 3

Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation

NCT07211958 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2025-11-25
Last updated
2026-09-25

Condition(s) studied

Acute Myeloid Leukemias

Investigational drug(s) / intervention(s)

Revumenib →PlaceboIntensive Chemotherapy Regimen

Revumenib: Participants will receive revumenib orally.

Placebo: Participants will receive placebo (non-active agent) orally.

Intensive Chemotherapy Regimen: Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion.

Study summary

The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * Participants must have newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy. * Presence of an NPM1 mutation. * Eastern Cooperative Oncology Group performance status ≤2 (≤1 if \>65 years old); Karnofsky or Lansky ≥40. * Have a life expectancy of ≥3 months as judged by the Investigator. * Negative serum pregnancy test. * Adequate liver, kidney, and cardiac function. Key Exclusion Criteria: * Diagnosis of active acute promyelocytic leukemia. * Active central nervous system disease. * Fridericia's corrected QT interval (QTcF) \>450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome. * Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion. * Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy). * Inability to swallow oral medication. * Pregnant or nursing females. * Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load. Note: Additional inclusion/exclusion criteria may apply, per protocol.

Primary outcome measure(s)

Trial sites (149)

FacilityCityRegionStatus
Clinical Trial Site Goodyear Arizona Recruiting
Clinical Trial Site Duarte California Recruiting
Clinical Trial Site Indianapolis Indiana Recruiting
Clinical Trial Site Shreveport Louisiana Recruiting
Clinical Trial Site Providence Rhode Island Recruiting
Clinical Trial Site Houston Texas Recruiting
Clinical Trial Site Adrogué Buenos Aires Recruiting
Clinical Trial Site Córdoba Córdoba Province Recruiting
Clinical Trial Site Buenos Aires Argentina Recruiting
Clinical Trial Site Salta Argentina Recruiting
Clinical Trial Site Kingswood New South Wales Recruiting
Clinical Trial Site Kogarah New South Wales Recruiting
Clinical Trial Site Randwick New South Wales Recruiting
Clinical Trial Site South Brisbane Queensland Recruiting
Clinical Trial Site Melbourne Victoria Recruiting
Clinical Trial Site Nedlands Western Australia Recruiting
Clinical Trial Site Perth Western Australia Recruiting
Clinical Trial Site Gosford Australia Recruiting
Clinical Trial Site Wollongong Australia Recruiting
Clinical Trial Site Klagenfurt Kaerten Recruiting
Clinical Trial Site Sankt Pölten Lower Austria Recruiting
Clinical Trial Site Graz Styria Recruiting
Clinical Trial Site Leoben Styria Recruiting
Clinical Trial Site Innsbruck Tyrol Recruiting
Clinical Trial Site Linz Austria Recruiting
Clinical Trial Site Vienna Austria Recruiting
Clinical Trial Site Ghent Belgium Recruiting
Clinical Trial Site São Paulo Estado de Bahia Recruiting
Clinical Trial Site Fortaleza Paraná Recruiting
Clinical Trial Site Barretos São Paulo Recruiting
Clinical Trial Site Jaú Brazil Recruiting
Clinical Trial Site Porto Alegre Brazil Recruiting
Clinical Trial Site London Ontario Recruiting
Clinical Trial Site Montreal Canada Recruiting
Clinical Trial Site Toronto Canada Recruiting
Clinical Trial Site Nice Alpes-Maritimes Recruiting
Clinical Trial Site Strasbourg Bas-Rhin Recruiting
Clinical Trial Site Marseille Bouches-Du-Rhône Recruiting
Clinical Trial Site Caen Calvados Recruiting
Clinical Trial Site Rouen Haute-Normandie Recruiting

+ 109 more sites — see the full list on the official registry below.

More Syndax Pharmaceuticals trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07211958 on ClinicalTrials.gov ↗ ← All trials in Germany